Founder/CEO of PleaseTech Ltd - collaborative document review and co-authoring for the enterprise.

This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

What is the EMA's transparency policy 70 and its impact on the publication of clinical data?

Without going into too much detail, the EMA’s Policy 70 concerns the publication of clinical data for medicinal products for human use (more information can be found here). This requires the publication on the EMA website of clinical data submitted by life science companies to the EMA in support of drug applications. As such, said clinical data is made publicly available to the whole world.

Pertinent to our interest, is the fact that the published documentation must be redacted to remove Personal Private Data (PPD) and Personally Identifiable Data (PID) and may also be redacted to remove some Commercially Confidential Data (CCI). So, in short, the submitting life science company needs to agree redactions (and for the CCI data, provide a justification for each redaction – the so called ‘Justification Table’) to the EMA and then provide the redacted documents for publication.

To further complicate the issue, PPD and PID data is relatively structured and standard and, therefore, can largely use a rules based approach to redaction. It is therefore a candidate for being subcontracted. Whereas CCI data is ‘softer’, typically lacking structure, and open to interpretation - so requiring justification. So, in practice, work on the different redaction types requires a different process and therefore needs to be undertaken by different teams – ideally in parallel as there is considerable time pressure.

Clearly this is a massive undertaking, especially as the policy is retrospective and therefore the documents will not have been written in a way that ever anticipated publication. So, in summary, life science companies submitting to the EMA have a short amount of time to redact thousands of documents, masking specified information only some of which is structured.

Where can PleaseReview assist?

Firstly, with the review of proposed redactions.

In my view, the redaction of a document is no different to any other document review process. Redactions must be proposed, reviewed, approved and then published. Initially, during the negotiation phase when CCI redactions are agreed with the EMA, a PDF document ‘marked for redaction’ will be the published output. Only when agreement is reached will the agreed redactions be applied to the document. At all stages review is a critical part of the process.

Proposed redactions need to be reviewed and that’s the first place PleaseReview fits in. If you are an existing PleaseReview user, your system, as it is configured today (no upgrades needed), can be used. PleaseReview will identify the areas ‘marked for redaction’ in a PDF file in PleaseReview. These can then be commented upon, discussed, agreed, etc. Areas missed can be identified. As always all this interaction is recorded and reported upon.

Secondly, with the latest and the greatest PleaseReview release (v6), not only do you get the areas ‘marked for redaction’ identified, but review participants can also propose redactions within PleaseReview. These are treated like any other proposed change to the document. As such, proposed redactions appear in the reconciliation report, which can be downloaded in Word and can therefore be copied and pasted into the Justification Table. So, collaborative redaction is introduced and available. Use it wisely!

Finally, we are busy working on v6.1 which will include several enhancements designed to streamline the process:

Redaction categorization. Precise requirements are still emerging and evolving, but initial indications are that different types of redaction (i.e. PPD, PID & CCI) will be required to have different properties (specifically color and overlay text) and so PleaseReview will include the ability to specify different redaction properties against Redaction Categories (the same as Comment Categories);

Round tripping of PDFs. It is important to be able to seamlessly import areas marked for redaction in PDF files into PleaseReview (i.e. convert them into PleaseReview proposed redactions rather than just identify them) and export them as the same so PleaseReview can be used to manipulate them (i.e. accept/reject/etc.);

Merge redactions. The ability to import PDF documents into PleaseReview with areas marked for redaction at any stage of the review cycle and have the proposed redactions imported and merged with the master document. This will allow multiple teams to work in parallel and then consolidate results;

Automatically produce a justification table minimizing manual work such as copy and paste.

So, in summary:

If you are current users of PleaseReview, with your existing system you can collaborate on the review of proposed redactions;

If you upgrade to PleaseReview v6 (the latest release), not only can you collaborate on the review of proposed redactions but also propose new redactions in PleaseReview;

When PleaseReview v6.1 is released, (Q1,17) – you will be able to do all of the above, plus you’ll also have a collaborative redaction environment, designed to assist the process of complying with the more subtle redaction requirements of Policy 70.

If you would like to learn more about PleaseReview's redaction capabilities or see a demonstration, please contact us.

Founder/CEO of PleaseTech Ltd - collaborative document review and co-authoring for the enterprise.

As the CEO of a technology company I must constantly consider the future. Naturally, a major consideration is whether a disruptive new technology is coming along which could make our products obsolete. For example, at a consumer level, Uber is severely damaging, if not destroying the traditional taxi business. As an Uber user myself, I can see why.

I believe that only the paranoid survive and I’m forever scanning the horizon for the missile which is aimed squarely at our technology - that of document review. What is this disruptive new technology (or, as Nicholas Taleb would put it, black swan event) which will hurt us?

Before I go any further let me define ‘document review’ as the term means different things in different industries. For us, document review is the generic term for the process by which peers, specialists (i.e. subject matter experts) or other interested parties comment upon and suggest changes to the content of a document prior to its finalization, approval and dissemination. Specifically, it is the review element of the document creation process. It can involve a single person (unusual), a small team of, say, five to twenty people (common) or a widespread team of 50+ reviewers (unusual). There may be several re-work and review iterations before the document is finalized.

Whether the document is an internal policy, procedure or specification or an external facing regulatory submission or proposal, the basic creation process is the same: create, review, finalize, approve, and finally, disseminate. I simply don’t see this process changing in the foreseeable future. No black swans there.

Now the good news for us is that PleaseTech operates in the B2B market space where disruptive new technology takes time to infiltrate. Large corporates are considered slow moving in this era of ever accelerating innovation. However, that doesn’t mean we can rest easy. The corollary of perceived slow movement is that when change does come, if you're not part of it, you're out!

One area of disruption which does impact us is the ongoing Office suite apps battle between Google and Microsoft. The Microsoft Office Suite has, for the last 20 years, been the dominant application for the creation of documents, spreadsheets and presentations in the business world. Our competitive advantage is based around our deep understanding of Microsoft Word and, to a lesser extent, the remainder of the Office Suite. So is the Office Suite under attack? The answer is yes - of course. The real question is, how successfully?

A couple of years ago it seemed that Google was making decent inroads into Microsoft’s market share with commentators making a comparison with the relative decline of use of Internet Explorer compared with Chrome. Indeed, in early 2015, Google announced its plan to ‘steal’ 80 percent of Microsoft’s market share. However, with the undoubted success of Office 365, Microsoft is fighting back and, last October in this very journal, Mary Branscombe penned an article entitled “Why companies are switching from Google Apps to Office 365”.

It goes beyond this. In general, users are resistant to change and those entering the workforce over the last few years have been used to Word from an early age. However, there is some evidence that Google is winning the battle in new smaller companies with younger workforces. But it will take a very long time for this advantage to filter through, meaning the Microsoft Office Suite will be the primary document creation mechanism for the foreseeable future.

There is, of course, the whole cloud versus on premise debate. Whilst the cloud is a fine invention and our cloud business is growing rapidly, not everyone wants their valuable intellectual property in the cloud.

A case in point would be a regulatory drug submission which contains clinical trials' data. Or a high value proposal for a defense contract. Is a company really prepared to entrust these valuable documents to a generic cloud? Obviously not, so we course, is where Microsoft wins again with its Office Suite. Its commercial competitors are all 100 percent cloud based.

What about the future of documents themselves? With individuals entering the workforce now being classified as ‘digital natives’, does the whole concept of a ‘document’ go away? Is this our black swan?

I’m of an age where I recall typing pools. Professional Engineers (as I was attempting to be as I entered the workforce back then) didn’t type their own documents. They were submitted to a typing pool, where they were created, printed and returned to you for review. A red pen was then used and the cycle continued. However, the introduction of PCs and word processors was a disruptive technology and the typing pool vanished. Yet, despite the disruption, the concept of paper document format lived on electronically with Adobe Acrobat. The delivery mechanism may have changed but the concept of a document is still very much alive.

Do digital natives think the same way? The research suggests not. They think in social media terms and moving them beyond this is one of the challenges educators have to deal with. They need to replace the informal language with more formal language that they can use in their essays, dissertations and other such submissions.

Can we see contracts being agreed in informal language? I think not. One of the first lessons in business is, understanding that the way something is worded can form the basis of a legal contract or instruction. The language used is all important. If it’s a specialist subject area, there is ‘accepted language’ pertaining to that specialism. The nuances of wording whatever the target dissemination mechanism (i.e. formal document, web page, email or, even, tweet) are all important.

So it seems to be that the document creation process of create, review, finalize, approve, disseminate isn’t going to change anytime soon – certainly not in my business career and probably not in my children’s business career.

It’s hard to see something replacing Word even with initiatives such as the Open Document Format (ODF) supported by the UK Government. However, the whole point of a Black Swan event is that it comes out of left field and is extremely difficult to predict. So who knows what the future holds? The corollary of perceived slow movement is that when change does come, if you're not part of it, you're out.

Founder/CEO of PleaseTech Ltd - collaborative document review and co-authoring for the enterprise.

As we come out of summer and into autumn/fall, here at PleaseTech we are gearing up for the imminent release of PleaseReview v6.

This is a massive task as, for the first time in the product’s history (well technically the second time as PleaseReview was brand new back in 2005), we are not releasing an incremental enhancement or improvement, but a completely new review interface. It’s a bit like starting from scratch with a new product, with all the accompanying training and marketing documentation.

For those of you who’ve not attend the v6 preview webinars or followed some of the announcements, one significant addition to PleaseReview v6 will be redaction. We’ve added redaction in response to recent EU privacy and transparency regulations, specifically the EU EMA (European Medicines Agency) transparency policy 70 on the publication of clinical data. Whilst this is directed towards the Life Science industry, we also believe that redaction is universally useful especially in light of the various Freedom of Information directives and the need to redact PPI data from documents supplied under these directives.

Policy 70 has significant implications for Life Science companies in that they will need to redact and negotiate these redactions with the EMA on their European submissions. I am particularly grateful to Dr Patrick Cullinan of Takeda whose presentation on this subject I attended at the Annual Regulatory Writing for Product Approvals Conference held in April in Philadelphia.

Patrick has kindly permitted us to use some of his material in our forthcoming webinar series on ‘EMA transparency policies - the deepening challenge of redaction and review’ scheduled for September. The webinar will examine the background to the redaction requirement (i.e. policy 70) and demonstrate how the new PleaseReview v6 redaction capability can help organizations rise to the challenge. You can sign up here: http://www.pleasetech.com/webinars.aspx.

Redaction is a natural bedfellow of review and, when you think about it, it is simply another form of proposed change to a document - and so fits into the PleaseReview model extremely well. In practice, using PleaseReview, redactions can be ‘proposed’, they can then be discussed, the proposals can be accepted or rejected with reasons given and finally the proposed redactions are recorded in the reconciliation report so there is full traceability of decisions.

It is, of course, vitally important that these redacted documents are high quality and accurate (like all regulatory documents) and therefore they need to be reviewed extensively. In this respect, PleaseReview also supports the review of PDF documents with sections ‘Marked for Redaction’ using Adobe Acrobat Professional mark-up. This particular functionality is already part of PleaseReview and is a natural consequence of the way PleaseReview currently handles PDF documents. For more information on this please contact the support team.

Of course, PleaseReview v6 isn't all about redaction. As I mentioned at the very beginning we are introducing a completely new modern responsive interface at the same time. Watch this space for further information but, in the meantime, for more information on the forthcoming redaction capabilities, sign-up for the webinar.

How much of the technology in your life fails to work when you need it to, or simply isn’t up to the job in question? How many times have you wandered up and down streets looking for a phone signal, or nearly thrown your laptop out of a window when software that’s supposed to make your life easier, leaves you with a headache?

Whilst all we want is the technology we have to work properly, the focus seems to be on bringing more and more new tech onto the market. Our needs are now anticipated before we know we even have them, yet looking for the right technology to meet our genuine needs can sometimes feel overwhelming. Is it the right solution to the problem in question? How reliable is it? Is it easy to use or am I going to need a degree in computing to figure it out? Yes, it looks great, but HOW MUCH?

And what exactly is it that stops us seeking out the right technology? Are we now so burnt by all the negative experiences that we’d rather put up with outdated and sometimes clumsy IT solutions, rather than seek out an alternative? At PleaseTech we’ve researched this topic a number of times, and as you’d expect, time and money come up time and time again as the key barriers.

Specifically looking at this from a business perspective, it’s the chicken and the egg, on the one hand poor processes cost organizations millions of dollars a year in lost productivity, whilst on the other you have employees struggling with poor software tools who don’t have the time to research an alternative. All too often, even if a solution is found, the cost is simply too high to get it past management. They eventually get fed up, quit and the business in question then has to spend thousands of dollars replacing skilled workers. In fact on average, a study from Oxford Economics found that the cost of replacing a member of staff is $44,798, as detailed in a survey conducted in 2015 by Osterman Research for PleaseTech.

And it’s not just the cost of recruitment that’s a problem. The Osterman research found that 77% of workers say their organizations report problems finding workers to recruit, and that IT plays an important role in their retention and motivation – for over half of respondents, it plays an important or even critical role.

Quite simply, better IT tools mean better results. Osterman found that for 85% of respondents, it resulted in increased productivity; for 64% the ability to make decisions more quickly; for 55% better results; for 53% a happier and more satisfactory working environment, and for almost one in five, they would be more likely to stay with an organization.

So what happens when you have that magic moment, you’re surfing the web or you're at a trade show when you come across a solution that could be the genuine answer to your problems? We already know that cost is an issue, so how do you build a business case?

Following on from our 2016 research with Osterman, we’ve been looking at exactly this issue. The research is nearly complete and we’ll be holding a series of webinars in the fall to look at the findings in detail.

Meanwhile, we’d love to hear about your experiences. How did you prove the business case, what clinched the deal? What were the key stumbling blocks you came up against? What’s life like now you’ve found a piece of software you don’t want to throw out of the window? Let us know...